Evaluating RO7759065 and Atezolizumab for advanced solid tumors
A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
PHASE1 · Genentech, Inc. · NCT06488716
This study is testing a new treatment called RO7759065, alone and with another drug called atezolizumab, to see if it can help people with advanced solid tumors feel better and fight their cancer.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. (industry) |
| Drugs / interventions | chemotherapy, immunotherapy, atezolizumab |
| Locations | 8 sites (Duarte, California and 7 other locations) |
| Trial ID | NCT06488716 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial aims to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of RO7759065, both as a standalone treatment and in combination with atezolizumab, in patients with locally advanced or metastatic solid tumors. The study is designed as an open-label, multicenter, dose escalation and expansion trial, focusing on patients with incurable malignancies. Participants will be monitored for tolerability and effectiveness, with specific eligibility criteria to ensure appropriate patient selection.
Who should consider this trial
Good fit: Ideal candidates include patients with locally advanced, recurrent, or metastatic solid tumors who have a life expectancy of at least 12 weeks and meet specific health criteria.
Not a fit: Patients who are pregnant, breastfeeding, or have active infections such as hepatitis or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are currently difficult to treat.
How similar studies have performed: Other studies have shown promise in using immunotherapy combinations for solid tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Life expectancy at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic and end-organ function * Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1 * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * Availability of representative tumor specimens required for patients in select cohorts. Exclusion Criteria: * Women who are pregnant or breastfeeding * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Active hepatitis B or C or tuberculosis * Positive test for human immunodeficiency virus (HIV) infection * Acute or chronic active Epstein-Barr virus (EBV) infection at screening * Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion * Primary, untreated, or active central nervous system (CNS) metastases * Active or history of autoimmune disease or immune deficiency * Prior allogeneic stem cell or organ transplantation * Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent * Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.
Where this trial is running
Duarte, California and 7 other locations
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (RECRUITING)
- University of Colorado — Aurora, Colorado, United States (RECRUITING)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (RECRUITING)
- Tennesse Oncology - NASH - SCRI - PPDS — Chattanooga, Tennessee, United States (RECRUITING)
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (RECRUITING)
- British Columbia Cancer Agency — Vancouver, British Columbia, Canada (RECRUITING)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
- Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Reference Study ID Number: GO45296 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumour